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    Summary
    EudraCT Number:2018-003089-14
    Sponsor's Protocol Code Number:CCTU0218
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-10-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2018-003089-14
    A.3Full title of the trial
    Azathioprine Immunosuppression and Disease Modification in Parkinson’s Disease (AZA-PD): a randomised double-blind placebo-controlled phase II trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can suppressing the immune system with azathioprine slow down the progression of Parkinson's disease?
    A.3.2Name or abbreviated title of the trial where available
    AZA-PD
    A.4.1Sponsor's protocol code numberCCTU0218
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCambridge University Hospitals NHS Foundation Trust and University of Cambridge
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCentre for Parkinson's Plus
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCambridge Clinical Trials Unit
    B.5.2Functional name of contact pointCarrie Bayliss
    B.5.3 Address:
    B.5.3.1Street AddressAddenbrooke's Hospital, Coton House Flat 63,
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB2 0QQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01223 348158
    B.5.6E-mailcctu@addenbrookes.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAzathioprine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAzathioprine
    D.3.9.1CAS number 446-86-6
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson's disease
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To conduct a double-blind randomised control trial of azathioprine versus placebo to provide ‘proof of concept’ through generating early phase data on the impact of azathioprine on clinical outcome measures of motor and cognitive function in PD.
    E.2.2Secondary objectives of the trial
    To provide ‘proof of mechanism’ through evaluating the effect of azathioprine on brain inflammation (measured with PK-11195 PET) and abnormalities of immune activation in blood and cerebrospinal fluid in PD.
    To provide data on the safety and tolerability of azathioprine in this population of patients with early Parkinson's disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    • Aged 50 years or over
    • Be a fluent English speaker
    • Have a diagnosis of PD according to UKPDS Brain Bank Criteria
    • Have a disease duration of <3 years
    • Have a probability of poor outcome (postural instability/dementia/death) at 5 years from diagnosis ≥50% [28]
    • Have adequate organ and marrow function, as defined below (measured within 42 days of first dose of trial medication):
    o Haemoglobin ≥ 110 g/L
    o Platelet count ≥ 130 x 109/L
    o Neutrophil count ≥ 1.5 x 109/L
    o Renal Function- Creatinine clearance ≥50mL/min
    o Hepatic function- Alanine aminotransferase (ALT) ≤2 times the institutional upper limit of normal (ULN) and total bilirubin ≤2 times the ULN.
    E.4Principal exclusion criteria
    The presence of any of the following will preclude participant inclusion:
    • Any use of immunomodulatory drugs such as azathioprine, mycophenolate, methotrexate, ciclosporin, cyclophosphamide within the last 12 months
    • Any previous use of rituximab or alemtuzumab
    • Previous treatment with corticosteroids for greater than 2 weeks, or any steroid use in the last 3 months
    • Regular use of non-steroidal anti-inflammatory drugs including aspirin>75mg, naproxen, ibuprofen, meloxicam on more than 2 days per week.
    • Known inflammatory or autoimmune disease
    • Chronic or latent infection
    • Active infection requiring the use of parenteral antimicrobial agents within 2 months prior to the first dose of study treatment.
    • Skin malignancy or solid organ malignancy within the last 5 years.
    • Current or previous haematological malignancy
    • Positive test for HIV or hepatitis
    • The inability to take or swallow oral medication
    • Dementia according to Movement Disorder Society dementia criteria
    • Thiopurine methyltransferase (TPMT) deficiency <10 pmol/h/mg Hb
    • Lack of immunity to VZV
    • Negative EBV IgG
    • Chronic liver disease
    • Renal impairment - creatinine clearance <50mL/min
    • Concomitant use of allopurinol (increases risk of myelotoxicity)
    • Any concurrent medical or psychiatric condition or disease (e.g. active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.
    • Receipt of live, attenuated vaccine within the last 30 days. Note: enrolled patients should not receive live, attenuated vaccine while receiving azathioprine nor within 30 days of last dose of azathioprine
    • • Women of childbearing potential. Female patients must be surgically sterile or be postmenopausal.
    o Postmenopausal is defined as spontaneous cessation of regular menses for at least 12 consecutive months or follicle-stimulating hormone (FSH) blood levels in the testing laboratory’s respective postmenopausal range with no alternative pathological or physiological cause.
    • Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy and for 6 months after completion of trial drug
    • Known hypersensitivity to azathioprine or its excipients
    • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before treatment protocol registration or is currently enrolled in an interventional investigational study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is change in MDS-UPDRS gait/axial score in the OFF state over the 12-month treatment period. This score is a sum of the points from the following sections of MDS-UPDRS part III (motor examination)
    • 3.1- speech
    • 3.2- facial expression
    • 3.9 – rising from a chair
    • 3.10- gait
    • 3.12- postural stability
    • 3.13- posture
    • 3.14- body bradykinesia

    The MDS-UPDRS part III examination will be videoed during the trial assessments, which will be used retrospectively to ensure inter-rater reliability.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The MDS-UPDRS will be assessed at the baseline visit and at the treatment end-point, following 12 months' of treatment with the IMP. At each timepoint, the gait/axial subscore will be recorded. The primary endpoint is the change in this score.
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient last visit (LPLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    As this is a phase II, proof of concept study, we do not plan to continue to provide azathioprine once the participants have completed the trial. This will be made clear to participants from the outset.

    Clinical care will continue to be provided by the participant's NHS consultant both during and after the trial.

    They will also be offered continued research follow-up through the Research Clinic at the John van Geest Centre for Brain Repair.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-06
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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